CRED 8 Presentations

01/07/2024

• Full list of contents for Module 1 is given in Notice to Applicants p 32-33: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf. • eCTD Specification for Module 1 (April 2021) EU Module 1 v3.0.4 • Read ‘pre authorisation guidance’ • CP: EMA website https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance • MRP/DCP: Heads of Agencies website MAA User Guide Heads of Medicines Agencies: Application for MA (hma.eu) and https://www.hma.eu/91.html and Best Practice Guide • Application form (eAF) is the same for all three procedures ( http://esubmission.ema.europa.eu/eaf/). • For MRP/DCP, list of national NCA contacts: https://www.hma.eu/nationalcontacts.html Considerations prior to compiling EU Module 1 (CP, MRP/DCP)

For publishing : • Read EU Module 1 eCTD Specification and Harmonised Technical Guidance for eCTD Submissions in the EU (see references slide).

The Organisation for Professionals in Regulatory Affairs

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Considerations prior to compiling Module 1

CP: See available EMA guidance • Review ‘validation issues frequently seen with initial MAAs’ (https://www.ema.europa.eu/en/documents/other/validation-issues-frequently-seen-initial-marketing authorisation-holders_en.pdf) • Use MAA Validation Checklist to avoid validation issue https://www.ema.europa.eu/documents/template-form/dossier-administrative-validation-checklist initial-marketing-authorisation-applications-applicants_en.zip . • EMA pre-submission interactions. For MAA start 6-7m prior to submission date. The pre submission interactions form (LINK) provides a check list of topics to consider when preparing an application. If the need for a meeting is identified, it will be held remotely (TC or virtual meeting facility). MRP/DCP : See ‘common grounds for invalidation/delaying validation’ Microsoft Word -Common grounds for invalidation-delaying validation_2007 0… (hma.eu) Start working as early as possible as it can often take longer than expected to finalise. • Speak with someone who has recently filed an MAA in the EU to benefit from their experience. • Look through Module 1 validation questions for other MAAs previously submitted by your company to get an idea of what issues the EMA/RMS pick up on.

The Organisation for Professionals in Regulatory Affairs

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